Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials Not Allowed)

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is launching a funding opportunity to establish a Center aimed at accelerating the development of treatments for Substance Use Disorders (SUDs) using drug repurposing and repositioning strategies. This initiative responds to the urgent need for more effective treatments for SUDs, which are often under-addressed due to limited pharmaceutical investment and the complex nature of addiction research. The proposed Center will serve as a central hub to assist academic and biotech investigators with the specialized resources and expertise needed to advance promising drug candidates through the translational research pipeline. The purpose of this initiative is to provide a structured yet adaptable infrastructure that supports the full continuum of drug development for repurposed or repositioned therapies, from early discovery through preclinical development and preparation for clinical translation. The Center will not conduct clinical trials but will focus on activities that set the stage for such trials, including tool and assay validation, protocol development, patient engagement strategies, and regulatory planning. It is designed to fill gaps in knowledge, experience, and infrastructure that often hinder academic and biotech entities from advancing their drug development efforts independently. A key function of the Center will be its role in community outreach and project sourcing. It will proactively engage researchers, solicit proposals, and implement a transparent process for selecting high-quality projects that align with its mission. The selected projects will receive expert support in developing Target Product Profiles (TPPs), navigating regulatory pathways, and conducting freedom-to-operate (FTO) and intellectual property (IP) analyses. These services will help ensure that new therapies not only meet scientific standards but are also commercially viable and legally defensible. The structure of the Center will include five required cores: Administrative, Translational Support, Patient Engagement, User Project Sourcing and Assessment, and FTO/IP Strategy/Market Access. Each core has specific responsibilities to ensure operational efficiency, scientific rigor, patient-centered approaches, strategic project selection, and commercial preparedness. For instance, the Patient Engagement Core will ensure that the needs and values of individuals affected by SUDs are integrated into all stages of development, from concept through protocol refinement. This emphasis on inclusivity and responsiveness aims to improve the likelihood of treatment adoption and impact. The funding opportunity will support one award under the U54 Specialized Center Cooperative Agreement mechanism, with NIDA intending to commit $2.5 million in fiscal year 2026. The maximum project period is five years, and while budgets are not capped, they must reflect actual project needs. Only new applications are allowed, and clinical trials are explicitly not permitted. Eligibility is broad, encompassing higher education institutions, nonprofits, for-profit organizations, government entities, tribal organizations, and even non-U.S. institutions. Applications will be accepted beginning December 28, 2025, with a submission deadline of January 28, 2026. Applicants must follow the NIH Multi-Project Application Guide and adhere to the NOFO’s specific instructions. All applications must be submitted electronically via NIH ASSIST or institutional systems compatible with Grants.gov. No late submissions will be accepted. Scientific and technical review will occur in July 2026, followed by council review in August 2026, with earliest award starts expected in September 2026. Contact for scientific inquiries is Dr. Elena Koustova ([email protected]), and for financial matters, the NIDA Grants Management Office at [email protected].

Align regulatory, patient, and translational plans early; ensure compliance with NIH submission format and core structure.